(12) United States Patent
`Woehr et a].
`
`(10) Patent N0.:
`(45) Date of Patent:
`
`US 7,736,339 B2
`Jun. 15, 2010
`
`USOO7736339B2
`
`CATHETER INSERTION DEVICE
`
`(56)
`
`References Cited
`
`(54)
`
`(75)
`
`Inventors: Kevin Woehr, Felsberg (DE); Kenneth
`C. Raines, Bethlehem, PA (US)
`
`(73)
`
`Assignee: B.Braun Melsungen AG, Melsungen
`(DE)
`
`(*)
`
`Notice:
`
`Subject to any disclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 663 days.
`
`(21)
`
`Appl. No.:
`
`10/520,325
`
`(22)
`
`(86)
`
`(87)
`
`(65)
`
`PCT Filed:
`
`Jul. 2, 2003
`
`PCT No.:
`
`PCT/EP03/07073
`
`§ 371 (0X1),
`(2), (4) Date:
`
`Sep. 12, 2005
`
`PCT Pub. No.: WO2004/004819
`
`PCT Pub. Date: Jan. 15, 2004
`
`Prior Publication Data
`
`US 2006/0155245 A1
`
`Jul. 13, 2006
`
`(30)
`1111. 4, 2002
`
`Foreign Application Priority Data
`
`(DE) .......................... .. 202 10 394 U
`
`(51)
`
`(52)
`(58)
`
`Int. Cl.
`(2006.01)
`A61M 5/00
`US. Cl. ................................ .. 604/164.08; 604/110
`
`Field of Classi?cation Search ............... .. 604/110,
`604/167, 263, 533, 164
`See application ?le for complete search history.
`
`DE
`
`U.S. PATENT DOCUMENTS
`3,562,097 A
`2/1971 Hazmburg
`(Continued)
`FOREIGN PATENT DOCUMENTS
`30 00 903 Al
`1/1980
`(Continued)
`OTHER PUBLICATIONS
`Patent Abstracts of Japan; entitled “Indwelling Puncture Needle With
`Wing Having Branching Part”, Application No. 11-021665, Publica
`tion No. 2000-217925; Date of Publication Aug. 8, 2000, Applicant
`Hanako Medical KK, 3 pgs.
`(Continued)
`Primary ExamineriKevin C Sirmons
`Assistant ExamineriMichael J Anderson
`(74) Attorney, Agent, or F irmiKlein, O’Neill & Singh, LLP
`
`ABSTRACT
`(57)
`The invention relates to a catheter insertion device compris
`ing: an approximately hollow cylindrical catheter sleeve (2),
`at whose distal end a catheter (4) is attached; a needle sleeve
`(8) with a hollow needle (9), which is attached thereto and
`which, when ready for use, extends through the catheter
`sleeve (2) and the catheter (4), and; a needle protective ele
`ment (13) that is arranged inside the catheter sleeve (2) while
`being able to move on the needle (9). Said needle protective
`element has an engaging section (130) that engages with an
`engaging device (9b), which is formed in the vicinity of the
`needle tip, when the hollow needle is withdrawn from the
`catheter sleeve (2). A check valve (7, 17) is placed inside the
`catheter sleeve (2) between the catheter (4) and the needle
`protective element (13). The hollow needle (9), when ready
`for use, extends through said check valve, and the check valve
`automatically closes once the needle is withdrawn.
`
`25 Claims, 3 Drawing Sheets
`
`5b
`
`5
`
`130
`
`13c
`
`9
`
`_,
`
`__ . .___ . ._
`
`‘
`
`13b
`
`9b
`
`\,
`13
`
`1
`
`B. Braun 2007
`
`

`

`US 7,736,339 B2
`Page2
`
`U.S. PATENT DOCUMENTS
`
`8/1971 Winnard
`3,601,151 A
`3/1979 Abramson
`4,143,853 A
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`5/1984 Gulaetal.
`4,447,230 A
`5/1984 Gereg
`4,449,693 A
`4/1985 Vaillancourt
`4,511,359 A
`4/1985 Vailancouit
`4,512,766 A
`3/1986 Inman et 31~
`4,578,063 A
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`4,673,399 A
`6/1987 Pruert
`4,765,588 A
`8/1988 Atkinson
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`4,795,432 A
`1/1989 Karczmer ................. .. 604/110
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`3/1989 Shimonakaetal.
`4,813,938 A
`3/1989 Raulerson ................. .. 604/158
`4,842,591 A
`6/1989 Luther
`4,846,809 A
`7/1989 Sims ........................ .. 604/198
`4,883,461 A 11/1989 Sawyer
`4,917,668 A
`4/1990 Haindl ................ .. 604/167.03
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`5/1990 Kulli
`4,929,235 A
`5/1990 Merryet al.
`4,929,241 A
`5/1990 Kulli ........................ .. 604/263
`4,944,725 A
`7/1990 McDonald ........... .. 604/164.08
`4,950,260 A
`8/1990 Bonaldo
`4,952,207 A
`8/1990 Lemieux
`4,964,854 A 10/1990 Luther
`4,966,586 A 10/1990 Vaillancourt
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`9/1991 Simon
`5,053,010 A 10/1991 McGaryetal.
`5,053,014 A 10/1991 Van Heugten
`5,053,017 A 10/1991 Chamuel .................. .. 604/192
`5,062,836 A 11/1991 Wendell
`5,071,413 A 12/1991 Utterberg
`5,084,023 A
`1/1992 LemieuX
`5,092,840 A
`3/1992 Healy
`5,108,374 A
`4/1992 Lemieux
`5,127,905 A
`7/1992 Lemieux
`5,135,504 A
`8/1992 McLees ............... .. 604/164.08
`5,147,327 A
`9/1992 Johnson
`5,154,703 A 10/1992 Bonaldo
`5,156,596 A 10/1992 Balbierz etal.
`5,158,554 A 10/1992 JePSOIl et 91-
`5,180,370 A
`1/1993 Gillespie
`5,188,607 A
`2/1993 Wu
`5,195,980 A
`3/1993 Catlin
`5,199,947 A
`4/1993 Lopez etal
`5215528 A
`6/1993 Purdyetal ---------- -- 604/16408
`5,234,410 A
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`5,242,393 A
`9/1993 Brimhalletal
`RE34,416 E
`10/1993 Lemieux
`5,251,873 A 10/1993 Atkinson et al.
`5,269,771 A 12/1993 Thomasetal-
`5,279,591 A
`1/1994 Simon
`5,295,657 A
`3/1994 Atkinson
`5,295,658 A
`3/1994 Atkinson etal
`5,300,033 A
`4/1994 Miller
`5,312,355 A
`5/1994 Lee
`5,322,517 A
`6/1994 Sircom et a1. ............. .. 604/198
`5,328,482 A
`7/1994 Sircom etal
`5,334,158 A
`8/1994 McLees .................... .. 604/110
`5,334,159 A
`8/1994 Turkel
`5,336,192 A
`8/1994 Palestrant
`5,344,161 A
`9/1994 Sandgren
`5,344,408 A
`9/1994 Partika ..................... .. 604/192
`5,344,414 A
`9/1994 Lopez etal
`5,352,205 A 10/1994 Dales et a1.
`5,353,837 A 10/1994 Faust
`5,360,413 A 11/1994 Leason et a1.
`5,380,305 A
`1/1995 Ghouri
`5,405,323 A
`4/1995 Rogers et a1.
`
`4/1995 Steinman
`5,409,461 A
`5/1995 Chang etal.
`5,419,766 A
`8/1995 Collinson et a1.
`5,439,451 A
`5,454,790 A 10/1995 Dubrul
`5,456,675 A 10/1995 Wolbring etal,
`5,453,640 A 10/1995 Genone
`5,458,658 A 10/1995 Sircom
`5,558,651 A
`9/1996 Crawfordetal.
`5,562,630 A 10/1996 Nichols
`5,562,633 A 10/1996 Wozencroft
`5,584,808 A 12/1996 Healy
`5,584,809 A 12/1996 Gaba
`5,601,536 A
`2/1997 Crawford etal.
`5,613,663 A
`3/1997 Schmidt et a1.
`5,634,913 A
`6/1997 Stinger
`5,651,772 A
`7/1997 Amen
`5,662,610 A
`9/1997 sircom
`5,688,253 A 11/1997 Paradis
`5,688,254 A 11/1997 Lopez et 31,
`5,699,821 A 12/1997 Paradis
`5,718,688 A
`2/1998 Wozencroft
`5,725,503 A
`3/1998 Amen
`5,738,144 A
`4/1998 Rogers
`5,749,857 A
`5/1998 Cuppy
`111535341 E
`7/1998 Frank et a1,
`5,776,116 A
`7/1998 Lopez etal.
`5,779,681 A
`7/1998 Bonn
`13391434 5
`55/1998 Pike
`5,797,897 A
`8/1998 Jepson etal,
`5,817,069 A 10/1998 Amen
`5,830,189 A 11/1998 Chang
`5,851,196 A 12/1998 Amen
`5,865,806 A
`2/1999 Howell
`5379337 A
`3/1999 Kumcinaet 31,
`5,911,705 A
`6/1999 Howell
`5,911,710 A
`6/1999 Barryetal,
`5,935,104 A
`8/1999 Janek et a1.
`5,954,698 A
`9/1999 Pike
`5,954,708 A
`9/1999 Lopez etal.
`5,967,490 A 10/1999 Pike
`5971957 A 10/1999 Lutheretal,
`6,001,080 A 12/1999 Kuracinaet a1.
`6,004,294 A 12/1999 Brimhall et a1.
`6,068,011 A
`5/2()()() Paradjs
`6,077,244 A *
`6/2000 Botich et a1. .............. .. 604/110
`6,030,137 A
`6/2000 Pike
`6,117,108 A *
`9/2000 Woehretal. .............. .. 604/110
`6,171,287 B1
`1/2001 Lynn et a1.
`6,203,527 B1* 3/2001 Zadini et a1. .............. .. 604/110
`6,213,978 B1* 4/2001 Voyten ................ .. 604/164.01
`6,223,060 B1
`5/2001 Howell
`6,245,048 B1
`6/2001 Fangrow, Jr. et a1.
`6,287,278 B1* 9/2001 Woehr et a1. .............. .. 604/110
`6,352,520 B1
`3/2002 Miyazakj
`6,379,333 B1
`4/2002 Brimhall et a1.
`6,379,372 B1
`4/2002 Dehdashtian et a1.
`6,443,927 Bl
`9/2002 Cook
`6,443,929 B1
`9/2002 Kuracina et a1.
`6,485,468 B2 11/2002 Vojtasek
`6,506,181 B2
`1/2003 Meng etal.
`6,533,759 B1
`3/2003 Watson et 31,
`6,585,704 B2
`7/2003 Luther et a1.
`6,595,954 B1
`7/2003 Luther et 31,
`6,595,955 B2
`7/2003 Ferguson et a1.
`6,616,630 B1
`9/2003 Woehr et a1.
`6,629,959 B2 10/2003 Kuracinaet a1.
`6,652,486 B2 11/2003 Bialeckiet 31,
`6,652,490 B2 11/2003 Howell
`6,692,471 B;
`2/2004 Boudreaux
`6,699,221 B2
`3/2004 Vaillancourt
`6,709,419 B2
`3/2004 Woehr
`6,719,726 B2
`4/2004 Meng etal.
`6,749,588 B1
`6/2004 Howell etal.
`
`2
`
`

`

`US 7,736,339 B2
`Page 3
`
`7/2004 East
`6,764,468 B1
`3/2005 Kuracinaetal.
`6,860,871 B2
`4/2005 Newton eta1.
`6,883,778 B1
`6/2005 Ferguson
`6,902,546 B2
`7/2005 Vojtasek
`6,916,311 B2
`6,972,002 B2* 12/2005 Thorne ................ .. 604/164.08
`7’125’396 132* 10/2006 Lemslng et al'
`7,374,554 132*
`5/2008 Menzletal ~~~~~~~~~~~~~~ ~~ 604/110
`
`* 2003/0199827 A1 10/2003 Thorne ................ .. 604/164.08 . . . . . . . . . . . . ..
`
`2004/0044313 A1
`3/2004 Nflkallma
`2004/0225260 A1* 11/2004 Vllla eta1. ........... .. 604/164.01
`2006/0155245 A1* 7/2006 Woehr ................. .. 604/164.08
`
`
`
`FOREIGN PATENT DOCUMENTS
`
`DE
`DE
`DE
`DE
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`EP
`GB
`W0
`
`31 00 622 A1
`32 10 148 A1
`44 34 569 A1
`201 04 539 U1
`0 414 997 A1
`0 554 841 A1
`0 747 084 A2
`0 799 626 A1
`1 101 508 A2
`1 101 508 A3
`1 180 381 A1
`1 240 916 B1
`1 374 942 A1
`1 374 942 B1
`2 118 440 A
`WO 97/45151
`
`4/1980
`9/1983
`3/1995
`1/2002
`4/1990
`8/1993
`12/1996
`10/1997
`5/2001
`8/2001
`2/2002
`9/2002
`1/2004
`1/2004
`11/1983
`12/1997
`
`12/1998
`wo 98/53875
`wo
`6/1999
`wo 99/26682
`wo
`wo 03011381 A1 * 2/2003
`wo
`wo wo 2004/004819 A1
`1/2004
`
`OTHER PUBLICATIONS
`PatentAbstracts of Japan; entitled “Safe Indwelling Needle”, Appli
`cationNo.2000-078335,PublicationNo.2001-259029,DateofPub
`
`
`lication Patent Abstracts of Japan; entitled “Safety Indwening Needle», '7
`
`Application No. 2000182911, Publication No. 2002-000727, Date
`OfPublication Jan‘s 2002 ApplicantMedikitKK 4pgs‘
`’
`’
`’
`Patent Abstracts of Japan; entitled “Indwelling Needle Structure”,
`Application No. 2001-363865, Publication No. 2003-175112, Date
`of Publication Jun. 24, 2003, Applicant Mitsubishi Pencil Co LTD, 5
`pgs~
`Patent Abstracts of Japan; entitled “Indwelling Needle Structure and
`Seal Material Used Therefor”, Application No. 2005-0351 12, Publi
`cation No. 2005-261938 A, Date ofPublication Sep. 29, 2005, Appli
`cant JMS Co LTD, 5 pgs.
`Patent Abstracts of Japan; entitled “Indwelling Needle”, Application
`No. 2004- 14393 1, Publication No. 2005-323762, Date ofPublication
`Nov. 24, 2005, Applicant Medikit KK, 4 pgs.
`Patent Abstracts of Japan; entitled “Indwelling Needle”, Application
`No. JP 1996-0040652, Publication No. JP 9206375, Date of Publi
`cation Aug. 12, 1997, Applicant Togo Medikit KK, 2 pgs.
`“Conical Fittings With 6% (Luer) Taper for Syringes, Needles and
`Certain Other Medical EquipmentiPart 2: Lock ?ttings,” Interna
`tional Standard, ISO 594-2, second edition, 1998, pp. 1-11, Technical
`Committee ISO/TC 84, Switzerland.
`
`* cited by examiner
`
`3
`
`

`

`US. Patent
`U.S. Patent
`
`Jun.15,2010
`Jun.15,2010
`
`Sheet10f3
`Sheet10f3
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`US 7,736,339 B2
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`Jun. 15, 2010
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`US 7,736,339 B2
`
`1
`CATHETER INSERTION DEVICE
`
`The invention relates to a catheter insertion device accord
`ing to the preamble of claim 1.
`
`CROSS-REFERENCE TO RELATED
`APPLICATION
`
`This is a US. national phase application of PCT applica
`tion No. PCTJEP2003/007073, ?led Jul. 2, 2003, which
`claims priority to German application Ser. No. 202 10 394.3,
`?led Jul. 4, 2002, the contents of these applications are
`expressly incorporated herein by reference.
`
`BACKGROUND
`
`A device of this kind is known from EP 352 928, wherein
`in a hollow catheter hub a needle guard element is arranged.
`On withdrawal of the hollow needle from the catheter over an
`engaging means near the tip of the hollow needle, the needle
`guard element engages with the engaging means and covers
`the tip when the hollow needle is separated from the catheter.
`In this design, after withdrawal of the hollow needle from the
`catheter, through this catheter blood can issue with which the
`operating personnel can come into contact.
`The invention is based on the object of designing a catheter
`insertion device of the type described above such that an
`out?ow of blood from the catheter is prevented after removal
`of the hollow needle with the needle guard element.
`
`SUMMARY
`
`This object is solved according to the invention by the
`features in the characterizing part of claim 1. In the ready
`position, a check valve is arranged in the catheter hub
`between the catheter and the needle guard element. Through
`this valve the hollow needle extends, so that after withdrawal
`of the hollow needle from the catheter the latter can be reli
`ably closed such that an out?ow of blood is prevented, while
`simultaneously the tip of the hollow needle is securely cov
`ered by the needle guard element so that the operating per
`sonnel cannot injure themselves on the needle tip.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`Exemplary embodiments of the invention are explained in
`more detail below with reference to the drawing, in which:
`FIG. 1 shows a longitudinal section through a catheter
`insertion device in the ready position,
`FIG. 2 shows the catheter insertion device with the hollow
`needle removed,
`FIG. 3 shows the device with an attached syringe,
`FIG. 4 shows a sectional view along the line A-A in FIG. 1,
`FIG. 5 shows a longitudinal section through another
`embodiment,
`FIG. 6 shows a view of the valve disc,
`FIG. 7 shows different views of a valve actuating element,
`FIG. 8 shows a longitudinal section through a further
`embodiment,
`FIG. 9 shows front views of the valve actuating element of
`FIG. 8, and
`FIG. 10 shows a longitudinal section through a further
`embodiment.
`
`DETAILED DESCRIPTION
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
`50
`
`60
`
`FIG. 1 shows a catheter insertion device 1 having a catheter
`hub 2 which has a two-part form in the embodiment. A distal
`hub element 3 of the catheter hub has a holding section 311 in
`which a catheter 4 is press-?tted. The proximal end of the hub
`
`65
`
`2
`element 3 has an enlarged diameter with regard to the distal
`end and forms a connecting section with a hub element 5
`whose distal end overlaps the proximal end of the hub ele
`ment 3 and which is provided at its proximal end with a Luer
`thread 6. Between the two hub elements 3 and 5, a check valve
`in the form of a valve disc 7 is inserted and is ?xed in place by
`the two hub elements 3 and 5.
`In the ready position according to FIG. 1, there is inserted
`in the catheter hub 2 a needle hub 8 to which a hollow needle
`9 is ?xed which extends through the valve disc 7 and the
`catheter 4 so that the needle tip 911 is exposed. Between needle
`hub 8 and valve disc 7 there is displaceably arranged in the
`proximal hub element 5 a valve actuating element 10 which
`has a truncated cone-shaped locating section 1011 which
`serves to open the valve disc 7, as FIG. 3 shows. On the
`proximal side, a plunger section 10b adjoins the locating
`section 1011 and has a hollow space for receiving a needle
`guard element 13. In the embodiment shown, the plunger
`section 10b is formed by two spaced plungers between which
`the needle guard element in the form of a spring clip 13 is
`inserted, as shown in the cross-sectional view in FIG. 4.
`On withdrawal of the hollow needle 9 from the catheter hub
`2, an engaging means 9b (FIG. 2), provided near the needle tip
`911 and having the form of a radial projection on the hollow
`needle which can be formed by light crimping, engages with
`the outer circumference of a bore in the rear wall 130 of the
`spring clip 13, so that the spring clip 13 is removed from the
`catheter hub with the needle 9, while simultaneously the
`spring arms 13a and 13b of the spring clip cover the needle
`tip, completely protecting and blocking it. In this separated
`position shown in FIG. 2, the valve disc 7, due to its elasticity,
`closes the through-hole for the hollow needle 9 so that no
`blood can ?ow out through the catheter 4. As FIG. 6 shows,
`the valve disc is provided for example with three slits 7a
`starting from the middle and extending radially over a short
`section X, forming elastic ?aps 7b therebetween which can be
`expanded by the hollow needle.
`FIG. 3 shows the insertion of a syringe 14 in the catheter
`hub 2, wherein the neck portion 14a of the syringe comes to
`abut on the plunger section 10b of the valve actuating element
`10 and presses it against the valve disc 7, so that the truncated
`cone-shaped locating section 1011 outwardly displaces the
`?aps 7b of the valve disc and thereby opens the valve, so that
`a liquid can be inserted from the syringe 14 into the catheter
`4.
`The incline of the truncated cone on the locating section
`1011 and the displacement path of the actuating element 10
`relative to the valve disc 7 are designed such that due to the
`elasticity of the material of the valve disc 7, the ?aps 7b
`displace the locating section 1011 to the right in FIG. 3 when
`the syringe 14 is removed from the catheter hub 2. Hereby, the
`valve disc 7 is automatically closed, as the position in FIG. 2
`shows.
`In the hub element 5, there is formed by a shoulder 5a a stop
`for the actuating element 10, to de?ne the position of the
`actuating element in the separated position in FIG. 2. Hereby,
`the truncated cone-shaped locating section 1011 lies near the
`stop 5a, while its distal end abuts on the valve disc 7 as shown
`in FIG. 2. The radial slits 7a of the valve disc 7 are designed
`such that in the ready position in FIG. 1, the ?aps 7b are bent
`radially upwards less than in the open position by the locating
`section 1011 in FIG. 3.
`As the cross-sectional view in FIG. 4 shows, the two plung
`ers lob of the valve actuating element 10 are guided in longi
`tudinal grooves 5e of the hub element 5 and they project
`radially inwards into the bore Sc of the hub element 5, so that
`they form an abutting surface for the neck portion 14a of the
`syringe 14. The bore Sc in the hub element 5 is formed slightly
`conically corresponding to the conical neck portion 14a of a
`syringe.
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`US 7,736,339 B2
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`3
`On the inner circumference of the bore Sc of the hub
`element 5, a further shoulder 5b having a smaller diameter is
`formed, on which the radially outer areas of the spring arms
`13a and 13b abut in the ready position in FIG. 1. Hereby, the
`spring clip 13 is ?xed in its position in the hub element 5.
`When the needle hub 8 with the hollow needle 9 is removed
`from the catheter hub 2, ?rst the spring clip 13 is held on the
`shoulder 5b by abutting until the radial projection 9b comes to
`abut on the rear wall 130 of the spring clip. In this position, the
`two spring arms 13a, 13b can be released from the shoulder
`5b and spring back inwards to cover the needle tip, as FIG. 2
`shows, whereupon the spring clip 13 with the hollow needle 9
`can be removed from the catheter hub.
`In the embodiment according to FIGS. 1 to 3, the distal end
`section of the hub element 5 is shrunk, welded or bonded onto
`the proximal end section of the hub element 3 after the valve
`actuating element 10 and the valve disc 7 are inserted in the
`hub element 5. It is also possible to join the two hub elements
`3 and 5 to one another, for example by a thread which is
`secured against loosening after assembly. The spring clip 13
`is inserted together with the hollow needle 9 in the bore Sc of
`the hub element 5 during assembly, wherein the radially outer
`areas of the spring arms 13a, 13b snap in at the shoulder 5b
`under elastic deformation.
`Preferably, in front of the shoulder 5b a projection 5b' can
`be formed in the bore Sc of the hub element, as shown in FIG.
`2. Hereby the snap-in and holding effect of the spring clip 13
`is increased.
`FIG. 5 shows a modi?ed embodiment of the connection of
`the two hub elements 3 and 5, in which two cylindrical sec
`tions 3b and 5d engage in one another. A thread can be
`provided between these two cylindrical sections. However, it
`is also possible to bond or weld these two sections.
`In this embodiment, the valve actuating element 10 is also
`modi?ed in relation to the embodiment of FIGS. 1 to 3. FIG.
`7a shows a side view of the approximately U-shaped actuat
`ing element 10 with the spring clip 13 inserted therein. As the
`side view rotated by 90° in FIG. 7b shows, the locating section
`1011 is partly ?attened on opposite sides so that the width of
`the plunger sections 10b extends into the locating section 10a.
`FIG. 70 is a front view from the left in FIG. 7b and shows the
`?attened structure of the locating section 10a. FIG. 7d is a
`sectional view along the central line in FIG. 7b. FIG. 7e shows
`a section through the valve actuating element 10 along the
`line B-B in FIG. 7d.
`FIG. 5 shows the lower half of the valve actuating element
`10 corresponding to the view in FIG. 7a, and the upper half in
`a sectional view rotated by 90° corresponding to FIG. 7b. The
`shoulder 511 for positioning the valve actuating element 10 in
`the hub element 5 is hereby formed on the ends of the dia
`metrically opposite grooves 5e (FIG. 4), so that the proximal
`ends of the plunger sections 10b abut on the shoulders 5a.
`Corresponding to the shoulder 5b in FIGS. 1 to 3 in the
`embodiment in FIG. 5, there is formed on the hub element 5
`a projection 5f which projects inwards at diametrically oppo
`site positions on the bore Sc of the hub element 5 and ?xes the
`spring clip 13 in the hub element 5 until the spring arms 13a,
`13b spring inwards over the needle tip and the spring clip with
`the hollow needle 9 is removed from the catheter hub.
`FIG. 8 shows a modi?ed embodiment having a hollow
`cylindrical valve actuating element 10 on whose inner cir
`cumference a projection 10f is formed for positioning the
`spring clip 13 inside the valve actuating element 10. FIG. 9a
`shows a front view of the valve actuating element 10 from the
`right and FIG. 9b shows a front view from the left in FIG. 8,
`wherein for locating the neck portion 14a of a syringe 14, in
`this embodiment radially inwardly projecting ribs 10e are
`formed which protrude radially into the bore Sc of the hub
`element 5, as the upper half of the valve actuating element in
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`FIG. 8 shows, in which the sectional view of the lower half of
`the valve actuating element 10 is shown rotated by 90° in
`relation to the upper half.
`FIG. 10 shows a modi?ed embodiment wherein between
`the two hub elements 3 and 5 a check valve 17 is inserted,
`which has a hollow cylindrical section 17b starting from a
`?ange section 1711 and abutting on the inner circumference of
`the hub element 3. From the inner circumference near the
`?ange section 1711 there start two opposite ?aps 170, which
`abut on the outer circumference of the hollow needle 9 in the
`ready position in FIG. 10. When the needle 9 is removed from
`the catheter hub 2, the elastically deformed ?aps 17c move
`inwards and close the valve. In this embodiment, an actuating
`element for opening the valve 17 is not necessary, because the
`pressure of the ?uid from the syringe 14 displaces the ?aps
`17c radially outwards so that the liquid can ?ow out through
`the valve 17. In this embodiment of a check valve, a so-called
`duck-bill valve is concerned, whose construction is in itself
`known.
`In FIG. 10, in order to allow the spring clip 13 to be held in
`the catheter hub during withdrawal of the hollow needle 9
`from the catheter hub 2 until the radial projection 9b on the
`hollow needle engages with the rear wall 130 to cover the
`needle tip, in this embodiment there is formed on the inner
`circumference of the proximal hub element 5 a projection 5f
`which extends radially inwards and on which the radially
`outer areas of the spring arms 13a and 13b come to abut and
`hold the spring clip until the spring arms spring back radially
`inwards to cover the needle tip. The inner diameter of the
`projection 5f is designed only slightly smaller than the maxi
`mum radial dimension at the spring arms 13a and 13b, so that
`during assembly the spring clip 13 can be inserted by slight
`pressure into the position in the catheter hub as shown in FIG.
`10.
`In the embodiment of a catheter insertion device according
`to FIGS. 1 to 9, in the position of the valve actuating element
`10 in FIG. 2 the valve disc 7 can be opened by low pressure
`produced by the syringe 4 for drawing off liquid from the
`catheter, wherein the elastic ?aps 7b are bent upward by the
`low pressure. In the embodiment of FIG. 10, a drawing-off of
`liquid from the catheter is not possible, because the duck-bill
`valve does not open when there is low pressure on the proxi
`mal side.
`It is convenient to fabricate the check valve in the form of
`a valve disc 7 or of the ?ap valve 17 from elastic silicon, while
`a correspondingly rigid plastic material is used for the hub
`elements 3 and 5 and for the valve actuating element 10.
`
`What is claimed is:
`1. A catheter insertion device comprising
`a hollow catheter hub having a catheter tube attached at a
`distal end thereof,
`a needle hub having a hollow needle attached thereto and
`extending through the catheter hub and the catheter tube
`when in a ready position,
`a needle guard element arranged displaceably on the
`needle in the catheter hub and having an engaging sec
`tion which engages with an engaging means formed near
`the needle tip when the hollow needle is removed from
`the catheter hub,
`wherein a check valve comprising a valve disc having
`radial slits starting from a middle section of the valve
`disc is disposed between the catheter tube and the needle
`guard element in the catheter hub through which the
`hollow needle extends in the ready position and which
`automatically closes after the removal of the needle, and
`wherein the check valve remains in the catheter hub
`when the hollow needle is removed from the catheter
`hub and the catheter tube; and
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`US 7,736,339 B2
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`5
`wherein a valve actuating element is displaceably guided in
`the catheter hub and has a hollow space for receiving the
`needle guard element.
`2. The device according to claim 1, wherein the catheter
`hub comprises a distal hub element and a proximal hub ele
`ment, and the check valve is held between the distal hub
`element and the proximal hub element, which are joined to
`one another.
`3. The device according to claim 1, wherein the check valve
`has a plurality of radially elastically expandable valve ?aps
`con?gured to be moved into an open position by ?uid pres
`sure generated from a syringe.
`4. The device according to claim 1, wherein the catheter
`hub comprises an inner circumference and a radial projection
`projecting radially from the inner circumference, which is
`con?gured to engage with the needle guard element in the
`ready position.
`5. The device according to claim 1, wherein the valve
`actuating element is formed as a hollow cylinder with a trun
`cated cone-shaped distal end section and comprising two
`proximally extending legs de?ning the hollow space for
`receiving the needle guard therebetween.
`6. The device according to claim 5, wherein the hollow
`cylindrical valve actuating element comprises an inner cir
`cumference and a radial projection.
`7. The device according to claim 1, wherein the valve
`actuating element has a truncated cone-shaped abutting sec
`tion.
`8. The device according to claim 1, wherein the needle
`guard element is formed as a spring clip which has diametri
`cally opposite spring arms starting from a rear wall provided
`with a bore, wherein bent end sections of the spring arms
`overlap and block the needle tip when the engaging means of
`the needle comes to abut on the rear wall.
`9. A catheter insertion device comprising:
`a catheter tube attached to an end of a catheter hub, the
`catheter tube comprising a lumen and the catheter hub
`comprising an interior cavity;
`a needle de?ning a needle axis attached to an end of a
`needle hub, said needle projecting through the lumen of
`the catheter tube;
`a valve for regulating ?uid ?ow positioned inside the inte
`rior cavity of the catheter hub and in mechanical com
`munication with a movable valve actuating element for
`opening the valve, and wherein the valve remains inside
`the interior cavity of the catheter hub when the needle is
`removed from the catheter tube and the catheter hub; and
`a needle guard element comprising two needle guard arms
`crossing the needle axis of the needle positioned inside
`the catheter hub adjacent the valve in a ready position.
`10. A catheter insertion device comprising:
`a catheter tube attached to an end of a catheter hub, the
`catheter tube comprising a lumen and the catheter hub
`comprising an interior cavity;
`a needle de?ning a needle axis attached to an end of a
`needle hub, said needle projecting through the lumen of
`the catheter tube and comprising an engaging section
`near a needle tip;
`a valve for regulating ?uid ?ow positioned inside the inte
`rior cavity of the catheter hub, said valve comprising an
`opening and the needle projecting through the opening,
`and wherein the valve remains inside the interior cavity
`of the catheter hub when the needle is removed from the
`catheter tube and the catheter hub;
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`a needle guard element comprising an opening adapted to
`contact the engaging section of the needle positioned
`between the valve and the needle hub; and
`wherein a valve actuating element is slidably displaced in
`the interior cavity of the catheter hub for opening the
`valve.
`11. The catheter insertion device of claim 9, wherein the
`two needle guard arms cross one another.
`12. The catheter insertion device of claim 9, wherein the
`needle guard element comprises a proximal wall comprising
`an opening having the needle passing therethrough.
`13. The catheter insertion device of claim 9, wherein the
`valve is a disc having at least one slit formed therein.
`14. The catheter insertion device of claim 9, wherein the
`movable valve actuating element comprises two leg sections
`comprising a space therebetween for accommodating the
`needle guard.
`15. The catheter insertion device of claim 10, wherein the
`engaging section is crimp.
`16. The catheter insertion device of claim 10, wherein the
`needle guard further comprises at least one arm comprising
`an apex abutting a shoulder located on the interior surface of
`the catheter hub.
`17. The catheter insertion device of claim 10, wherein the
`needle guard comprises two arms that intersect one another.
`18. The catheter insertion device of claim 10, wherein the
`valve actuating element comprises two leg sections compris
`ing a space therebetween for accommodating the needle
`guard.
`19. The catheter insertion device of claim 10, wherein the
`needle guard is made from a metal material.
`20. The device according to claim 1, further comprising a
`valve actuating element formed as a hollow cylinder with a
`truncated cone-shaped distal end section, with two legs
`extending proximally therefrom, the two proximally extend
`ing legs de?ning a space therebetween con?gured for receiv
`ing the needle guard element.
`21. The device according to claim 20, wherein the catheter
`hub comprises a diameter variation on an inner circumference
`of the catheter hub located between a distal end and a proxi
`mal end of the valve actuating element.
`22. The catheter insertion device according to claim 9,
`wherein the movable valve actuating element is formed as a
`hollow cylinder with a truncated cone-shaped distal end sec
`tion, comprising two proximally extending legs de?ning a
`space therebetween con?gured to receive the needle guard
`element.
`23. The catheter insertion device according to claim 9,
`wherein the catheter hub comprises a diameter variation on an
`inner circumference of the catheter hub located between a
`distal end and a proximal end of the valve actuating element
`when in the ready position.
`24. The catheter insertion device according to claim 10,
`wherein the valve actuating element is formed as a hollow
`cylinder with a truncated cone-shaped distal end section,
`comprising two proximally extending legs de?ning a space
`therebetween con?gu